General Principles of Software Validation; Final Guidance for Industry and...
...Terms such as beta test, site validation, user acceptance test, installation verification, and installation testing have all been.....defined user requirements;validation protocol used;acceptance criteria;test cases and.....automated test equipment used for inspection and acceptance of finished circuit boards in..
http://www.fda.gov/cdrh/comp/guidance/938.html (score=100)

General Principles of Software Validation; Final Guidance for Industry and...
...Test plans and test cases should be created as early in the software development process as feasible.They.....applies to any software used to automate device design, testing, component acceptance.....Test procedures, test data, and test results should be documented in a manner permitting..
http://www.fda.gov/cdrh/comp/guidance/938.pdf (score=99)

NADA 139-191
...Dogs are owned and housed in the homes of non-biased participants who regularly test dog.....Test Animals.. Forty dogs of all sizes, both sexes and many breeds were hand offered the.....Acceptance Test.. 1. Name and address of investigator who did the study: Mr. C. W..
http://www.fda.gov/cvm/efoi/section1/139191101387.html (score=54)

Guidance for Industry and FDA Staff - Mammography Facility Surveys,...
...regarded as an "acceptance" test for the equipment and an annual survey alone is not.....sufficient documentation that clarifies both the testing performed and the test results.....07age quality test described undef thebweekly quality control requirem)8.7(e)-0.3(nts..
http://www.fda.gov/cdrh/dmqrp/6409.pdf (score=31)

Document
...in response to several other comments, early test planning, but we have.. see objective.....acceptance test plan. We disagree and.. conflicting requirements, as required by.....specified that test plans and test cases.. the verification procedure was.. requirements to the safety..
http://www.fda.gov/OHRMS/DOCKETS/98fr/011102a.pdf (score=31)

MEDICAL PHYSICIST'S ANNUAL SURVEY REQUIREMENTS
...A summary of the annual test results listed above, including pass/fail designations and.....It may be regarded as an "acceptance" test for the equipment and an annual survey alone is.....The survey report must contain sufficient information documenting that each test was..
http://www.fda.gov/cdrh/dmqrp/6409.HTML (score=31)

QSR Manual
...Other device output information is used to create a DMR drawing such as for a test or an.....This drawing also includes some of the quality acceptance criteria for evaluating the.....The device master record also contains test and inspection procedures and data forms that..
http://www.fda.gov/cdrh/qsr/08dmr.html (score=31)

...We disagree and have retained the recommendations for early test planning, but we have specified that test plans and test cases.....Several comments questioned the idea of early test planning, which was recommended in the.....The fact that there is insufficient information for a particular test plan is valuable..
http://www.fda.gov/ohrms/dockets/98fr/011102a.htm (score=31)

MDI and DPI Drug Products
...stability test storage conditions. Additional studies should be performed to characterize.....drug products should be controlled with appropriate acceptance criteria and test methods.....Appropriate acceptance criteria and tests should be instituted to control those drug.. 236..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=11)

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...process test and the drug substance test, the acceptance criterion for the in-process test.....Justification for an in-process test that is used in lieu of a drug substance test should.....numeric ranges, limits, or acceptance criteria for intermediates, postsynthesis materials..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=10)

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...process test and the drug substance test, the acceptance criterion for the in-process test.....Justification for an in-process test that is used in lieu of a drug substance test should.....numeric ranges, limits, or acceptance criteria for intermediates, postsynthesis materials..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=10)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...If the result of any BET exceeds the acceptance limit, or if a sterility test is positive.....of false-positive results arises in the sampling and transfer of the test aliquot from the.....ensure that each batch of PET drug product meets its established acceptance criteria, 1201..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=10)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...If the result of any BET exceeds the acceptance limit, or if a sterility test is positive for microbial growth, a complete.....The reliability of the supplier's test results can be established by conducting.....When the quality control unit has determined that a lot of material has met all acceptance..
http://www.fda.gov/cder/guidance/4259dft.htm (score=10)

510(k) Submissions for Coagulation Instruments - Guidance for Industry and...
...and testing and should briefly describe the methods or tests used and a summary of the.....data or description of the acceptance criteria applied to address the risks identified in.....When describing your acceptance criteria or summary data, we recommend that you include..
http://www.fda.gov/cdrh/oivd/guidance/1223.pdf (score=10)

FR Notice ICH Guidance on Q6A Specifications: Test Procedures and Acceptance...
...For oral products requiring reconstitution, a test and acceptance criterion for water content.....When antimicrobial preservative content testing is performed as an in-process test, the acceptance.....When antioxidant content testing is performed as an in-process test, the acceptance criteria should..
http://www.fda.gov/cber/gdlns/frich122900.htm (score=9)

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